Kornimate/medical-research-clean huggingface dataset:
effectiveness of low volume and low pressure in severe hypoxemic patients

Conditions: Hypoxemia; Ards

Summary: the present study set up to answer two questions: (a) "how low tidal volume must be to provide protective ventilatory settings able to minimize the risk of death due to ventilator-induced lung injury (vili)?"; (b) "if protection from vili is better achieved by targeting the driving pressure instead of the tidal volume, what is the optimal target for the driving pressure?". solving these questions is pivotal for clinicians to personalized and precise mechanical ventilation practices to reduce the risk of vili and avoid unnecessary risks associated to protective ventilatory settings. two multicenter emulated target trials will be performed using data collected with the electronic health record margheritatre, to investigate the effect of low tidal volumes (6.0 to 8.0 ml/kg pbw vs 8.0 to 10.0 ml/kg pbw) and low driving pressures (7.0-12.0 cmh2o vs 12.0-18.0 cmh2o), respectively. data will be used to obtain the dose-response curve of lower vt and lower ∆p in mechanically ventilated patients with acute severe hypoxemia.


Eligibility criteria:
inclusion criteria: all the following conditions present continuously for 24 hours commencing within 36 hours of icu admission, while the patient is undergoing invasive mechanical ventilation in either flow or pressure- regulated assist/controlled modes: 1. arterial oxygen tension (pao2) to inspiratory oxygen fraction (fio2) ratio p/f ≤ 300 mmhg 2. hypoxemia developed within one week of a known clinical insult 3. hypoxemia not fully explained by cardiac failure or fluid overload\* exclusion criteria: 1. pregnancy 2. expected duration of mechanical ventilation \< 48h 3. severe or moderate copd 4. chronic liver disease 5. acute brain injury 6. patient admitted for palliative sedation 7. tumor with metastases 8. prior cardiac arrest 9. new york heart association class iv 10. acute coronary syndrome 11. patients transferred from other icus 12. patients transferred to the icu from the emergency department after a duration exceeding 24 hours in the emergency department 13. patients on pressure support ventilation and/or patients in whom end-inspiratory plateau pressure was not measured
aqueous humor dynamics of ncx 470 ophthalmic solution

Conditions: Open Angle Glaucoma

Summary: this is a double-masked, placebo-controlled study which will determine the action of ncx 470 ophthalmic solution, 0.1% on aqueous humor dynamic parameters in healthy volunteers or subjects with oht.


Eligibility criteria:
inclusion criteria: 1. ≥18 years of age 2. either gender 3. subjects without glaucoma 4. qualifying iop at screening visit exclusion criteria: 1. narrow anterior chamber angles or disqualifying central corneal thickness in either eye 2. clinically significant ocular disease in either eye 3. uncontrolled systemic disease 4. serious hypersensitivity to topical anesthetic eye drops 5. subjects with a known hypersensitivity or contraindications to any of the ingredients in the study medications

Keywords: glaucoma ncx 470 nitric oxide prostaglandin analogue
a trial to evaluate the safety of intratumoral vcl-im01 followed by electroporation in metastatic melanoma

Conditions: Metastatic Melanoma

Summary: to evaluate the safety of intratumorally injected vcl-im01 at doses of 0.5 mg (1 tumor), 1.5 mg (1 tumor), 5 mg (1 tumor), 10 mg (2 tumors, 5 mg per tumor) and 15 mg (3 tumors, 5 mg per tumor) followed by electroporation.

eligible subjects will receive intratumoral injections of vcl-im01 followed by electroporation of the injected tumor(s). subjects will be enrolled to receive one course of treatment. a course of treatment is two cycles, each cycle consisting of four weekly injection/electroporation administrations followed by an observation period of two weeks. subjects' tumors will be evaluated at screening, at the end of cycle 2, and at six months (week 26) from the initial drug administration.

Eligibility criteria:
inclusion criteria - key criteria include: * confirmed recurrent metastatic melanoma * tumor(s) to be treated must be at least 1 cm by 1 cm, and be accessible to treatment * able to carry out normal daily activities and light work without assistance * not currently receiving chemotherapy or immunotherapy * normal blood chemistries and blood cell counts (elevation of ldh to less than or equal to 1.5 times normal is allowed) * able and willing to give informed consent. exclusion criteria - key criteria include: * history of brain tumors (resected or stereotactically treated is allowed) * history of liver tumors * subjects whose melanoma can be cured by surgery * pregnant * subjects with electronic pacemakers, defibrillators, or any other implanted electronic device.

Keywords: melanoma electroporation il-2
analyse of diagnosis value of keloid on 68ga- fapi-04 pet-ct

Conditions: Keloid

Summary: keloid scars are common benign fibroproliferative reticular dermal lesions. fibroblasts are considered to be the key cellular mediators of fibrogenesis in keloid scars. thus this prospective study is going to investigate whether 68ga-fapi pet/ct may provide evidence for diagnosis and evaluate the effectiveness of treatment.

keloid scars are common benign fibroproliferative reticular dermal lesions with unknown etiology and ill-defined management with a high rate of recurrence post-surgery. the progression of keloids is characterized by increased deposition of extracellular matrix proteins, invasion of the surrounding healthy skin, and inflammation. fibroblast activation protein alpha (fap-a) and dipeptidyl peptidase iv(dppiv) are proteases located at the plasma membrane promoting cell invasiveness and tumor growth and have been previously associated with keloid scars. thus this prospective study is going to investigate whether 68ga-fapi pet/ct may be superior for diagnosis, therapy response assessment, and follow-up of keloid. this study aims to explore whether fap plays a role in the mechanisms of scar tissue progression, as well as the diagnostic efficacy of these two imaging agents, and to be able to evaluate relevant treatments for personalized therapy.

Eligibility criteria:
inclusion criteria: * suspected or confirmed pulmonary fibrosis patients; * signed written consent. exclusion criteria: * pregnancy; * breastfeeding; * known allergy against fapi * any medical condition that in the opinion of the investigator may significantly interfere with study compliance
relationship between topiramate use and ocular angle status

Conditions: Glaucoma, Angle-Closure

Summary: we test the hypothesis whether topiramate narrows the angles which may render asians more likely to suffer from acute angle closure glaucoma.

topiramate is approved for the treatment of epilepsy and prophylaxis of migraine attacks. there were case reports of acute angle closure glaucoma (aacg) associated with its use. aacg is particularly common in asians because of a higher prevalence of narrow angle., we test the hypothesis whether topiramate narrows the angles which may render them more likely to suffer from aacg.

Eligibility criteria:
inclusion criteria: * participants aged 18-75 with an indication for starting topiramate. exclusion criteria: * patients with known allergy or intolerance to topiramate. * recent exposure to topiramate (\<3 months). * moderate to severe renal failure. * known history of renal calculi or hepatic failure * inability to give informed consent. * pregnant women or women of child-bearing age who do not practise an acceptable means of contraception. * patients known to have angle-closure glaucoma.

Keywords: side effects topiramate
methadone in post-herpetic neuralgia pain

Conditions: Post-herpetic Neuralgia

Summary: neuropathic pain is a common condition and affecting 40 to 70% of the general population. post-herpetic neuralgia is a condition almost complex and requires a multi modal treatment. aim: this is a pilot proof-of-principle study designed to evaluate the use of low-dose methadone in post-herpetic neuralgia patients who remained refractory after first and second line treatment for post-herpetic neuralgia (phn) and had indication for the association of an opioid agent to their current drug regimen.


Eligibility criteria:
inclusion criteria: * patients with chronic (\>6 months) symptomatic phn * with visual analogical scale \>40/100mm * use of first and second line drugs (tricyclic antidepressants, venlafaxine and gabapentinoids) exclusion criteria: * don't full the criteria above

Keywords: neuropathic pain, post-herpetic neuralgia, methadone,
pilot study: combining nutritional supplements with standard antidepressant to treat depression.

Conditions: Depression

Summary: \*\*this study never received irb approval and no participants were ever enrolled\*\* the purpose of this study is to determine if adding over the counter nutritional supplements will have a benefit to participants currently taking prescribed antidepressants who have not experienced complete remission of their depression symptoms.

inclusion criteria: detroit va patients with major depression, mild to moderate treated with an ssri and not having complete remission of symptoms as defined by "feeling their normal selves" randomized into two groups: experimental: will receive month supply of deplin 15mg, l-tyrosine 6g/d into 2 divided doses, and l-tryptophan 2g/d into 2 divided doses. control: will receive month supply of deplin 15mg , and 2 placebo pills. beck depression scale (bdi-2) to be administered at baseline and every 2 weeks for 1 month.

Eligibility criteria:
\*\*this study never received irb approval and no participants were enrolled\*\* inclusion criteria: * veterans administration medical center patients with major depression, mild to moderate treated with an ssri and not having complete remission of symptoms.

Keywords: depression ssri nutritional supplements beck depression scale
a validation study of force sense measurement

Conditions: Knee Injuries; Proprioceptive Disorders

Summary: the term proprioception was first introduced by sherrington in 1906, who described it as a type of feedback from the limbs to the central nervous system. based on the early descriptions by sherrington and others, the contemporary terms of joint position sense (jps), kinaesthesia (perception of active and passive motion), and sense of tension or force sense are considered sub modalities of proprioception. for the extremity joints, goniometers (universal, bubble, digital) can also be used to measure active jps. depending on the device used and the extremity joint measured, reliability and measurement error of active movement goniometry can range widely and this should be carefully considered if goniometry is used to measure active jps of extremity joints. kinesthesia, can be measured by calculating the passive motion detection threshold of individuals. the force sense (fs), commonly assessed using force reproduction, has also been used as a measure of proprioception. assessing force reproduction by limb matching involves the use of a reference force, usually determined as a percentage of a maximal voluntary isometric contraction (mvic), and attempting to replicate that force. proprioception can be decreased in those who suffer from knee injury. because patients with severe degenerative joint disease often require total knee arthroplasty to relieve pain, improve stability, and restore function. due to problems such as oedema, immobilization and subjective pain after surgery, it is difficult to evaluate proprioception with joint repositioning method. in such cases, the assessment of fs could be of particular interest in the knee region. fs can also be measured by the accuracy of reproducing a specific target force. for example, the pressure biofeedback device (pbd) used for assessing the cranio-cervical flexion test could be considered a method of assessing force sense in the cervical spine. the ability to hold steadily or the accuracy in achieving and maintaining a desired pressure can be used. however, for the knee region, there is no method to measure the force sense via a device that can be used in clinical practice. the aim of this study was to establish a method for measuring fs that could be applied quickly and practically in the clinic, and to correlate the outcomes with surface electromyographic (emg) muscle activation levels from m. quadriceps femoris to demonstrate the applicability and objectivity of this method.


Eligibility criteria:
inclusion criteria: * without chronic knee problems * without chronic neurologic problems * without chronic rheumatological problems * without cognitive problems exclusion criteria: * osteoporosis

Keywords: force sense knee joint proprioception sphygmomanometer surface emg
elobixibat for chronic constipation without defecation desire

Conditions: Chronic Constipation

Summary: patients of chronic constipation without defecation desire will be orally administered elobixibat 10 mg once daily before meals for 4 weeks. the primary endpoint of the pre/post comparative study will be the percentage of improvement in bowel movements from week 2 of the observation period at week 4 of the treatment period.


Eligibility criteria:
inclusion criteria: at the time of provisional registration * patients diagnosed with chronic constipation using the rome iv criteria for the diagnosis of chronic constipation * age: 20 years or older (at the time of obtaining consent) * gender: any * outpatients * patients for whom written consent can be obtained * patients who can record defecation, etc. in the patient diary at the time of registration: dosing start criteria patients with the following ・'loss of defecation desire'\* in the second week of the observation period (1 week before the start of the treatment period) \*"loss of defecation desire " refers to patients whose "presence or absence of defecation desire" on the patient questionnaire was "4. almost never" or "5. never". exclusion criteria: at the time of temporary registration exclude patients with any of the following conditions * patients with organ-related constipation or suspected of having organ-related constipation * patients with or suspected of having functional ileus * patients with or suspected of having inguinal hernia * patients with a history of open abdominal surgery within 12 weeks prior to obtaining consent (excluding appendicitis resection) * patients with a history of surgical or endoscopic procedures related to gallbladder resection and papillotomy * patients with complications of malignancy however, patients who have undergone radical surgery or who have completed chemotherapy or radiotherapy may be registered. * pregnant women, lactating women, women who may be currently pregnant, or patients who cannot give consent to use contraception while participating in the study * patients with serious renal, hepatic, or cardiac disease * patients with drug allergy to the study drug * patients who are participating in other clinical studies, or who have participated in other clinical studies within 4 weeks prior to obtaining consent however, observational studies are excluded. * other patients who are judged by the principal investigator or sub-investigator to be inappropriate for this study. at the time of registration: dosing start criteria * patients who increased the dose of concomitantly restricted drugs during the observation period * patients who used concomitantly prohibited drugs during the observation period
assessment of the effects of early proprioceptive stimulations in patients with severe traumatic brain injury

Conditions: Traumatic Brain Injuries

Summary: "severe traumatic brain injury (tbi) is a serious condition, common in young adults. it leads to sensorimotor and cognitive sequelae that hinder social reintegration. neuronal plasticity must be used quickly before natural recovery impedes neuronal regrowth. in this respect, stopping sedation as soon as possible and early mobilization, even if the patients are unconscious, are recognized as useful measures to promote recovery. however, at the early stage, the environment of the icu and the acute condition of the patients limit the rehabilitation possibilities. in such a context, functional proprioceptive stimulations (vibramoov™ system, techno concept, france) could be a tool of interest. by using the proprioceptive signatures of cyclic movements, proprioceptive stimulations can elicit the illusion of these movements. a motor response can even be obtained through the interactions between the peripheral nervous system and the central nervous system. finally, such stimulations facilitate the initiation of the mimicked movements. some studies have already shown the benefits of proprioceptive vibrations. however, so far, these benefits have only been studied at the chronic stage of neurological diseases. the investigators hypothesized that early functional proprioceptive stimulations (fps) may reduce spasticity and promote recovery in patients with severe traumatic brain injury. to test the hypothesis, the investigators conduct a randomized controlled trial on patients with severe traumatic brain injury. every patient will be included as soon as possible in the icu and receive either fps, either sham stimulations to the joints of the lower limbs, 4 times a week during 8 weeks. the primary outcome measures will assess spasticity. the investigators also assess pain, coma recovery; muscle wasting and cognitive impairments. "


Eligibility criteria:
inclusion criteria: * severe tbi : glasgow coma score (gcs) ≤ 8 (11) * age ≥ 18 years old * no pregnancy * not being under guardianship * be affiliated to the french social security system exclusion criteria: * orthopedic lesions or any medical condition that prevent the implementation of the protocol within ten days post-injury * traumatic sci

Keywords: traumatic brain injuries proprioceptive stimulation vibration spasticity intensive care units
comparison in frequency of hypotension between remimazolam and propofol in hip surgery

Conditions: Remimazolam; Propofol; Orthopedic Procedures; Sedatives; Anesthesia, Spinal

Summary: the purpose of this study is to compare the incidence of hypotension between remimazolam and propofol for intraoperative sedation in patients undergoing hip surgery with spinal anesthesia.


Eligibility criteria:
inclusion criteria: * asa physical status 1-3 * patients scheduled for hip joint surgery under spinal anesthesia and sedation with propofol or remimzolam exclusion criteria: * patients who refuse to participate in this study * patients with uncontrolled high blood pressure, hyperthyroidism, dementia in the inability to communicate, or symptomatic coronary artery disease * patients with an allergy to propofol, fentanyl, or bupivacaine * patients contraindicated for spinal anesthesia, such as coagulopathy, severe aortic stenosis/mitral stenosis, and active infection on lumbar region * patients judged to be inappropriate for this study
glutamine supplementation in cystic fibrosis

Conditions: Cystic Fibrosis; Immune Function

Summary: patients with cystic fibrosis develop frequent and potentially life-threatening lung infections. recent studies suggest that the nutrient "glutamine" may help the body fight off infection. glutamine is an amino acid; a type of nutrient the body requires to build muscle. it is one of the building blocks of protein. during an illness, blood levels of glutamine tend to be lower than normal. also, many patients with cystic fibrosis have difficulty getting normal levels of nutrients from food. the aim of this study is to see if patients with cystic fibrosis have low levels of glutamine when they experience an infection, and whether a dietary glutamine supplement taken daily for three months can raise these levels. we also want to see if this supplement can improve other blood markers of immunity (the body's ability to defend itself from infection). we hope to enroll 40 people with cystic fibrosis who experience a lung infection, over a one year period, into this study.


Eligibility criteria:
inclusion criteria: * adult patients (≥ 18 years of age) with cystic fibrosis who give informed consent * patients must have a clinically diagnosed pulmonary exacerbation at time of enrollment, characterized by clinical requirement for oral or intravenous antibiotics associated with pulmonary symptoms such as increased cough or decreased forced expiratory volumes (fev1) * participants must agree to provide phlebotomy samples and complete all study protocol at presentation and at return visits exclusion criteria: * any patients taking specific glutamine supplements within 30 days of enrollment * pregnant or lactating women * patients involved in any other research protocol involving intake of a study drug, in the last 60 days. * patients who are chronically immunosuppressed due to drugs or immunosuppressive illness other than cf (e.g. hiv/aids, chronic autoimmune disease) * patients receiving hemodialysis or with creatinine \>2.5mg/dl * patients with liver failure from any cause * patients with a history of cancer within the past 12 months or currently receiving anti-neoplastic therapy. * patients with a history of seizures

Keywords: glutamine
temporary transvenous pacemaker placement by intracavitary electrocardiogram monitoring

Conditions: Bradycardia; Syncope; Bradyarrhythmia; Brady-tachy Syndrome; Tachycardia Bradycardia; AVB - Atrioventricular Block; Tachyarrhythmia

Summary: traditional temporary pacing catheter insertion by intracavitary electrocardiogram (ic-ecg) monitoring which only monitoring tip polar, the negative one. the investigators modified the technique by monitoring both negative and positive polar which will be precisely locating catheter tip and indicating the direction of the catheter tip. extensively used temporary pacing catheter tip has two electrodes which are about 1 cm apart. distal electrode is negative (-) and active, proximal electrode is positive (+) and indifferent. investigators use both distal (-) and proximal (+) electrodes which can be attached to any two of the v leads, record as v(-) and v(+). monitoring positions of the electrodes by v(-) and v(+) could provide more information about the tip position. comparing the qrs amplitudes between v(-) and v(+), when catheter tip enters right ventricle chamber: the case of v(-) \> v(+) infers tip toward apex ventricle wall ; conversely, the case of v(-)\<v(+) indicates tip directs to outflow tract. the investigators hypothesis this monitoring will help precisely placement.


Eligibility criteria:
inclusion criteria: * patients with indication of temporary transvenous pacing exclusion criteria: * not applicate to ic-ecg monitoring.